FDA.reportPublic FDA data

Allopurinol

Product NDC
23155-694
11-digit product format
231550694
Labeler code
23155
Product ID
23155-694_43518352-e2b6-4133-97fc-860d3eeea074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204467
Marketing category
ANDA
Marketing start
2020-09-22
Marketing end
2029-10-31
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319, 197320

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ee55bab-4ea8-ac26-c688-380cfbcd5c03Product name720260127
de89a493-168f-43fa-9852-1f15e00dbb17Product name120221110
4a2a34d6-1853-423b-9e0c-360370b95802Product name120171006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-694-01Allopurinol100 in 1 BOTTLETABLET1008
23155-694-05Allopurinol500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-694-01EA - Each23155-694955db619-93ea-4cbd-bb9c-cff43f44cbdf12021-01-08
23155-694-05EA - Each23155-69409bca254-9ac3-4c6d-8535-807cc8a9745812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-694ALLOPURINOL TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20231212_ad6950d4-2cdd-44ac-9b8a-120716460e70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN30529a62-f95a-40e0-b4c5-2cfc09232068104
197320allopurinol 300 MG Oral TabletSCD30529a62-f95a-40e0-b4c5-2cfc09232068104
197319allopurinol 100 MG Oral TabletPSNad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletPSNad6950d4-2cdd-44ac-9b8a-120716460e708
197319allopurinol 100 MG Oral TabletSCDad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletSCDad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletPSN7f9ad8db-ae68-4a0c-b858-1e727bc981303
197320allopurinol 300 MG Oral TabletPSNf3bd5852-8e43-6b5d-e053-2995a90a194f3
197320allopurinol 300 MG Oral TabletSCD7f9ad8db-ae68-4a0c-b858-1e727bc981303
197320allopurinol 300 MG Oral TabletSCDf3bd5852-8e43-6b5d-e053-2995a90a194f3
197320allopurinol 300 MG Oral TabletPSN0f8b97d0-4d0b-9f4a-e063-6294a90a033f2
197320allopurinol 300 MG Oral TabletSCD0f8b97d0-4d0b-9f4a-e063-6294a90a033f2
197320allopurinol 300 MG Oral TabletPSN1b1c5cde-b2ed-ebc8-e063-6394a90a66c61
197320allopurinol 300 MG Oral TabletSCD1b1c5cde-b2ed-ebc8-e063-6394a90a66c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-694-0123155069401100 TABLET in 1 BOTTLE (23155-694-01) 100 tablet2020-09-220000-00-00NoNoCurrent
23155-694-0223155069402500 TABLET in 1 BOTTLE (23155-694-02) 500 tablet2020-09-220000-00-00NoNoCurrent
23155-694-0523155069405500 TABLET in 1 BOTTLE (23155-694-05) 500 tablet2020-09-222029-10-31NoNoCurrent